Leaflet Mechanical Stress in Different Designs and Generations of Transcatheter Aortic Valves: An in Vitro Study.

Background: It is unknown whether bioprostheses used for transcatheter aortic valve implantation will have similar long-term durability as those used for surgical aortic valve replacement. Repetitive mechanical stress applied to the valve leaflets, particularly during diastole, is the main determinant of structural valve deterioration. Leaflet mechanical stress cannot be measured in vivo. The objective of this in vitro/in silico study was thus to compare the magnitude and regional distribution of leaflet mechanical stress in old vs new generations of self-expanding (SE) vs balloon expandable (BE) transcatheter heart valves (THVs). Methods: A double activation simulator was used for in vitro testing of two generations of SE THV (Medtronic CoreValve 26 mm and EVOLUT PRO 26 mm) and two generations of BE THV (Edwards SAPIEN 23 mm vs SAPIEN-3 23 mm). These THVs were implanted within a 21-mm aortic annulus. A noncontact system based on stereophotogammetry and digital image correlation with high spatial and temporal resolution (2000 img/sec) was used to visualize the valve leaflet motion and perform the three-dimensional analysis. A finite element model of the valve was developed, and the leaflet deformation obtained from the digital image correlation analysis was applied to the finite element model to calculate local leaflet mechanical stress during diastole. Results: The maximum von Mises leaflet stress was higher in early vs new THV generation (p < 0.05) and in BE vs SE THV (p < 0.05): early generation BE: 2.48 vs SE: 1.40 MPa; new generation BE: 1.68 vs SE: 1.07 MPa. For both types of THV, the highest values of leaflet stress were primarily observed in the upper leaflet edge near the commissures and to a lesser extent in the mid-portion of the leaflet body, which is the area where structural leaflet deterioration most often occurs in vivo. Conclusions: The results of this in vitro/in silico study suggest that: i) Newer generations of THVs have ∼30% lower leaflet mechanical stress than the early generations; ii) For a given generation, SE THVs have lower leaflet mechanical stress than BE THVs. Further studies are needed to determine if these differences between new vs early THV generations and between SE vs BE THVs will translate into significant differences in long-term valve durability in vivo.

In vitro Doppler versus catheter transvalvular pressure gradients in balloon-expandable versus self-expanding transcatheter aortic valves.

OBJECTIVES: The objective of this in vitro study was to compare Doppler versus catheter transvalvular pressure gradients (TPG) in third generations balloon-expandable (BE) versus self-expanding (SE) transcatheter heart valves (THV). BACKGROUND: TPG is a key parameter to assess and follow valve hemodynamic function following transcatheter aortic valve implantation (TAVI). It remains uncertain and debated whether, and to which extent, TPGs differ according to the type of THV, that is, BE versus SE and to the method used for TPG measurement, that is, Doppler echocardiography versus cardiac catheterization. METHODS: The CoreValve EVOLUT PRO 26 mm and the SAPIEN 3 23 mm THVs were tested in a left heart simulator using a 21 mm aortic annulus under following conditions: heart rate: 70 bpm, mean aortic pressure: 100 mmHg, stroke volume: 30, 70 and 100 ml. Mean TPGs were measured by continuous-wave Doppler and by micro-tip pressure catheters positioned in the left ventricle and at 50 mm downstream to the tip of the THV leaflets. RESULTS: Doppler TPGs (9.5 ± 3.9 mmHg) were on average 40.5 ± 13.9% higher (p < 0.001) than catheter TPGs (6.3 ± 3.4 mmHg). Both Doppler and catheter TPGs were lower (p = 0.003) in the SE versus BE THVs (Doppler: 8.7 ± 3.5 vs. 10.7 ± 4.6; catheter: 5.0 ± 1.7 mmHg vs. 7.1 ± 2.2). The Doppler versus catheter difference in TPG increased with the higher flow conditions. The Doppler versus catheter difference in TPG was similar in BE versus SE THVs (3.6 ± 1.1 vs. 3.7 ± 1.4 mmHg or 42 ± 9 vs. 47 ± 9%; p = 0.58) overall and in each flow conditions. CONCLUSION: The Doppler TPGs are, on average, 40% higher than the catheter TPGs for both BE and SE THVs. The SE THV had lower Doppler and catheter TPGs compared to the BE THV, at normal and high flow states. The absolute and percent differences between Doppler versus catheter TPGs were similar in BE versus SE THVs.

Leaflet stress quantification of porcine vs bovine surgical bioprostheses: an in vitro study.

Calcified aortic stenoses are among the most prevalent form of cardiovascular diseases in the industrialized countries. This progressive disease, with no effective medical therapy, ultimately requires aortic valve replacement - either a surgical or very recently transcatheter aortic valve implantation. Increase leaflet mechanical stress is one of the main determinants of the structural deterioration of bioprosthetic aortic valves. We applied a coupled in vitro/in silico method to compare the timing, magnitude, and regional distribution of leaflet mechanical stress in porcine versus pericardial bioprostheses (Mosaic and Trifecta). A double activation simulator was used for in vitro testing of a bioprosthesis with externally mounted pericardium (Abbott, Trifecta) and a bioprosthesis with internally mounted porcine valve (Medtronic, Mosaic). A non-contact system based on stereophotogammetry and digital image correlation (DIC) with high spatial and temporal resolution (2000 img/s) was used to visualize the valve leaflet motion and perform the three-dimensional analysis. A finite element model of the valve was developed, and the leaflet deformation obtained from the DIC analysis was applied to the finite element model calculate local leaflet mechanical stress throughout the cardiac cycle. The maximum leaflet stress was higher with the pericardial versus the porcine bioprosthesis (2.03 vs. 1.30 MPa) For both bioprostheses the highest values of leaflet stress occurred during diastole and were primarily observed in the upper leaflet edge near the commissures and to a lesser extent in the mid-portion of the leaflet body. In conclusion, the coupled in vitro/in silico method described in this study shows that the highest levels of leaflet stress occur in the regions of the commissures and mid-portion of the leaflet body. This method may have important insight with regard to bioprosthetic valve durability. Our results suggest that, compared to porcine bioprostheses, those with externally mounted pericardium have higher leaflet mechanical stress, which may translate into shorter durability.

In vitro correlation between the effective and geometric orifice area in aortic stenosis.

BACKGROUND: Planimetry of aortic stenosis can be performed when Doppler measurements are unavailable. We sought to evaluate if, as advised in guidelines, the geometric orifice area (GOA) threshold value of 1 cm² was concordant with the threshold of 1 cm² of the effective orifice area (EOA), and the factors influencing the contraction coefficient (EOA/GOA ratio). METHODS: In an in vitro mock circulatory system, we tested 6 degrees of AS severity (3 severe and 3 non-severe), and 3 levels of flow (<150 ml/s, 150-200 ml/s, >250 ml/s). The EOA was calculated by Doppler-echocardiography, and the GOA was measured with dedicated software after camera acquisition. RESULTS: In all but the very low flow condition, an EOA of 1 cm² corresponded to a GOA of 1.2 cm². The contraction coefficient increased with both the flow and the stenosis severity. For very severe stenoses, the EOA and the GOA were interchangeable. CONCLUSION: As observed in clinical studies, the GOA was larger than the EOA, and a GOA between 1 and 1.2 cm² should not discard the possibility of severe aortic stenosis.

Effects of hemodynamic conditions and valve sizing on leaflet bending stress in self-expanding transcatheter aortic valve: An in vitro study.

Transcatheter aortic valve (TAV) replacement has become a viable alternative to surgery for high and intermediate risk patients with severe aortic stenosis. This technology may extend to the younger and lower risk patients. In this population, long-term durability of the TAV is key. Increased leaflet mechanical stress is one of the main determinants of valve structural deterioration. This in vitro study aims at evaluating leaflet bending stress (LBS) in the self-expanding TAV for different valve sizes, stroke volumes (SV), and degrees of valve oversizing (OS). Three different sizes (23, 26, and 29 mm) of CoreValve (CV) were tested on a pulse duplicator in annulus size ranging from 17 to 26 mm. Leaflet bending stress and bending of the leaflet coaptation line in diastole pinwheeling index (PI) were measured using high-speed camera imaging (1000 images/s). For each given CV and annulus size, geometric orifice area (GOA) increased significantly with OS (P < .001) and SV (P = .001). LBS decreased with increasing prosthesis size and aortic annulus (AA) size while increasing with SV (P < .03). The largest value of peak LBS (3.79 MPa) was obtained with the CV 23 mm in AA of 17 mm (%OS = 35%), SV 90 mL and the smallest value (0.99 MPa) for the CV 29 mm in AA of 26 mm (%OS = 12%), SV 30 mL. On multivariable analysis, LBS increased independently with larger OS, smaller AA size and higher SV. The PI increased with decreasing AA size and increasing OS. Moderate valve OS, such as generally used for transcatheter aortic valve implantation, is associated with increased LBS during valve opening and closing, especially in small annuli. Hence, TAV OS may negatively impact long-term valve durability.

A bench test study of bioprosthetic valve fracture performed before versus after transcatheter valve-in-valve intervention.

AIMS: Bioprosthetic valve fracture (BVF) may improve transvalvular gradients and transcatheter heart valve (THV) expansion during VIV interventions. However, the optimal timing of BVF is unknown. We assessed the impact of timing of BVF (before versus after) for valve-in-valve (VIV) intervention, on hydrodynamic function and THV expansion. METHODS AND RESULTS: Three THV designs were assessed, a 23 mm SAPIEN 3 (S3), small ACURATE neo (ACn) and 23 mm Evolut R, deployed into 21 mm Mitroflow bioprosthetic surgical valves. We evaluated each THV in three groups: 1) no BVF, 2) BVF before VIV, and 3) BVF after VIV. Hydrodynamic testing was performed using a pulse duplicator to ISO 5840:2013 standard. Transvalvular gradients were lower when BVF was performed after VIV for the S3 (no BVF 15.5 mmHg, BVF before VIV 8.0 mmHg, BVF after VIV 5.6 mmHg), and the ACn (no BVF 9.8 mmHg, BVF before VIV 8.4 mmHg, BVF after VIV 5.1 mmHg). Transvalvular gradients were similar for the Evolut R, irrespective of performance of BVF or timing of BVF. BVF performed after VIV resulted in better expansion in all three THV designs. The ACn and Evolut R samples all had a mild degree of pinwheeling, and BVF timing did not impact on pinwheeling severity. The S3 samples had severe pinwheeling with no BVF, and significant improvement in pinwheeling when BVF was performed after VIV. CONCLUSIONS: BVF performed after VIV was associated with superior THV expansion in all three THV designs tested, with lower residual transvalvular gradients in the S3 and ACn THVs. The Evolut R had similar hydrodynamic performance irrespective of BVF timing. Timing of BVF has potential implications on THV function.

A novel method to quantitate bioprosthetic valve leaflet mechanical stress: a numerical and in vitro study.

An original in vitro/in silico method was developed to estimate the local and global mechanical stress applied on the bioprosthetic valve leaflet, which can be important for better understanding of the valve durability. A non-contact system based on stereophotogammetry and digital image correlation enabled filming and studying the valve leaflet movement frame by frame and performing three-dimensional analysis. The deformation was applied in a finite element model in order to calculate the local mechanical stress applied. High stress regions were primarily observed in the upper leaflet edge and belly and to a lesser extent at the free leaflet edge.

Valve-in-Valve Transcatheter Aortic Valve Replacement and Bioprosthetic Valve Fracture Comparing Different Transcatheter Heart Valve Designs: An Ex Vivo Bench Study.

OBJECTIVES: The authors assessed the effect of valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) followed by bioprosthetic valve fracture (BVF), testing different transcatheter heart valve (THV) designs in an ex vivo bench study. BACKGROUND: Bioprosthetic valve fracture can be performed to improve residual transvalvular gradients following VIV TAVR. METHODS: The authors evaluated VIV TAVR and BVF with the SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) and ACURATE neo (Boston Scientific Corporation, Natick, Massachusetts) THVs. A 20-mm and 23-mm S3 were deployed in a 19-mm and 21-mm Mitroflow (Sorin Group USA, Arvada, Colorado), respectively. A small ACURATE neo was deployed in both sizes of Mitroflow tested. VIV TAVR samples underwent multimodality imaging, and hydrodynamic evaluation before and after BVF. RESULTS: A high implantation was required to enable full expansion of the upper crown of the ACURATE neo and allow optimal leaflet function. Marked underexpansion of the lower crown of the THV within the surgical valve was also observed. Before BVF, VIV TAVR in the 19-mm Mitroflow had high transvalvular gradients using either THV design (22.0 mm Hg S3, and 19.1 mm Hg ACURATE neo). After BVF, gradients improved and were similar for both THVs (14.2 mm Hg S3, and 13.8 mm Hg ACURATE neo). The effective orifice area increased with BVF from 1.2 to 1.6 cm2 with the S3 and from 1.4 to 1.6 cm2 with the ACURATE neo. Before BVF, VIV TAVR with the ACURATE neo in the 21-mm Mitroflow had lower gradients compared with S3 (11.3 mm Hg vs. 16 mm Hg). However, after BVF valve gradients were similar for both THVs (8.4 mm Hg ACURATE neo vs. 7.8 mm Hg S3). The effective orifice area increased from 1.5 to 2.1 cm2 with the S3 and from 1.8 to 2.2 cm2 with the ACURATE neo. CONCLUSIONS: BVF performed after VIV TAVR results in improved residual gradients. Following BVF, residual gradients were similar irrespective of THV design. Use of a small ACURATE neo for VIV TAVR in small (≤21 mm) surgical valves may be associated with challenges in achieving optimum THV position and expansion. BVF could be considered in selected clinical cases.

Overexpansion of the SAPIEN 3 Transcatheter Heart Valve: An Ex Vivo Bench Study.

OBJECTIVES: This study assessed the effect of overexpansion beyond labeled size (diameter) of transcatheter heart valves through an ex vivo bench study. BACKGROUND: Transcatheter heart valves function optimally when expanded to specific dimensions. However, clinicians may sometimes wish to overexpand balloon-expandable valves to address specific clinical challenges. The implications of overexpansion have assumed considerable importance, and objective information to guide practice is limited. METHODS: We evaluated SAPIEN 3 transcatheter heart valves (Edwards Lifesciences, Irvine, California). Valves (diameters of 23, 26, and 29 mm) were expanded to nominal dimensions, and then incrementally overexpanded with balloons sized 1-, 2-, and 3-mm larger than the recommended diameter. Valves underwent visual, microcomputed tomography, and hydrodynamic evaluation at various degrees of overexpansion. RESULTS: SAPIEN 3 valves with labeled diameters of 23, 26, and 29 mm could be incrementally overexpanded to midvalve diameters of 26.4, 28.4, and 31.2 mm, respectively. With overexpansion, there was visible restriction of the valve leaflets, which was particularly evident with the smaller valves. After maximal overexpansion of a 26-mm valve a leaflet tear was observed. High-speed video demonstrated impaired leaflet motion of both the 23- and 26-mm valves and hydrodynamic testing documented a regurgitant fraction for the 23- and 26-mm valves above accepted international standards. The maximally overexpanded 29-mm SAPIEN 3 still had relatively normal leaflet motion and excellent hydrodynamic function. Durability was not specifically evaluated. CONCLUSIONS: Overexpansion of balloon-expandable valves is possible. However, excessive overexpansion may be associated with impaired hydrodynamic function, acute leaflet failure, and reduced durability. Smaller valves may be at greater risk with overexpansion than larger valves. Overexpansion is best avoided unless clinical circumstances are compelling.

Effect of size and position of self-expanding transcatheter valve on haemodynamics following valve-in-valve procedure in small surgical bioprostheses: an in vitro study.

AIMS: The valve-in-valve (ViV) procedure has become a valuable alternative for the treatment of failed surgical bioprostheses (BP) in high-risk patients. However, in small BP, the clinical outcomes have been suboptimal due to high post-procedural gradients. We aimed to examine the effect of size and position of the self-expanding transcatheter heart valve (THV) CoreValve on the haemodynamics of ViV within small BP. METHODS AND RESULTS: Sizes 23 and 26 mm of the CoreValve were implanted in sizes 19 and 21 mm of three BP models: Trifecta, Mitroflow and Epic Supra. The THV was tested in three positions -normal (manufacturer recommendation), low (4 mm below normal) and high (4 mm above normal)- using a pulse duplicator. Haemodynamics were assessed by Doppler echocardiography and flowmeter, and GOA with a high-speed camera. Higher implantation was associated with lower residual gradients (normal position: -9%, high: -25% versus low). High position was, however, associated with increased risk of regurgitation in the Mitroflow and embolisation in the Epic Supra. Using a 26 mm THV instead of a 23 mm was associated with larger EOAs in the Trifecta, smaller in the Mitroflow, and increased risk of embolisation in the Epic Supra. CONCLUSIONS: Supra-annular positioning of the CoreValve THV is associated with improved post-ViV haemodynamics in small surgical BP. The haemodynamic outcomes are highly dependent on the model and size of surgical BP.